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Areas in Orthopaedic Surgery Where Negligence has Occurred is Uncertain Particularly Around the Operation Itself

Medico Legal

by Mr. Ian Forster - Consultant Orthopaedic Surgeon MBBS, FRCS, FRCS(Ed)

Consent
A common area is around consent. Claimants often say they hadn’t discussed the details of an operation
when the consent form suggests they had.

This is always difficult. Some time ago a paper was published which looked at what patients understood after discussing the operation and taking consent. Simply after a full explanation the patients were asked to recall what they had been told. The answer was very little.

In the time before an operation when consent is usually taken or confirmed the anxiety of the situation makes it very difficult for patients.

To this end the consent form has space to add in the aim of the operation and its benefits and possible complications.Some forms are specific to the operation and list all this in print form. As with any such form it is difficult to know whether this was all explained to the patient.

However, this is only the form.Consent starts when the patient is first seen. At that time they would be listed for operation or sent for further tests. A full explanation should start then. If the patient is reviewed again further counselling should occur and by the time the form is signed a patient should be well versed in the details of their op. This usually makes the signing a formality and tends to reduce anxiety.

I recently was asked to advise on a case where a two stage procedure was to be carried out. Each stage required a separate form but both were signed at the
same time and countersigned immediately before each procedure. Ive never seen this before but I suppose it is logical since the time between each procedure was 6 weeks. Although the forms were clear the patient was adamant that she hadn’t understood what was being undertaken and that a realignment procedure to be performed at the second op was not explained to her although it was clearly written on the form. This is a very difficult legal area.

Wrong Site Surgery
Clearly no one wants to operate on the wrong limb but it still happens, although rarely. It takes several people to be off their guard at the same time. There is no issue with liability here. Patients are often comforted to know that steps towards prevention have been undertaken.

To avoid wrong site surgery in Orthopaedics there is a rule that all sites will be marked on the day of surgery preferably by the surgeon.At its simplest this an arrow in marker pen at the site of surgery so that it is visible in the operative field after draping. There are many checks in the anaesthetic room before
anaesthesia and consent and marking are the first ones!

Some surgeons add the operation title to the mark along with their initials, whilst an extra check covers a wider area of the operative field.

Despite all this, things can happen such as the anaesthetic technician putting the tourniquet on the wrong leg and everyone else assuming that its right.

After such an event,whether or not there is litigation, there is a Serious Case Review carried out by the hospital to find out why the mistake happened and any recommendations as to avoidance in the future.

Around the Operation
DVT’s are a common source of disquiet amongst patients,particularly whether prophylaxis should be given. The area is often a subject of hospital protocol and is covered by NICE recommendations.

Its important to realise that there are several types of prophylaxis, mechanical and chemical.

Mechanical -anti-embolic stockings and foot/calf pumps

Chemical - small doses of anticoagulant drugs either by injection or by mouth.

Where a patient is having joint replacement the answer is easy,provided there are no contraindications. For a hip replacement the patient should have 4 weeks chemical and six weeks mechanical and for a knee replacement 2 weeks chemical and 6 weeks mechanical.

In general both groups would have pumps for the first day or so and then stockings. All the anticoagulants cause bleeding whether by injection or mouth and as a result,from a practical point of view,patients have injections whilst in hospital and tablets at home. It is perfectly easy to teach patients to give themselves the injections if that is the preferred method.I did this myself.

No treatment starts until after the op and if excessive bleeding occurs the treatment is stopped. In the replacement scenario it is usual to give prophylaxis and it would be difficult not to do this. However, there are units who might give only aspirin for prophylaxis.This is not recommended by NICE and is less effective but if a hospital makes it protocol or sufficient surgeons agree this could be defensible.

The problem lies in other operations.It is generally accepted that without specific indications, no prophylaxis is given after an arthroscopy. The intermediate operations such as ligament reconstruction and patella realignment. are a problem. There is a period of inactivity after the op but only for a short time. The patient was sometimes braced, reducing their activity. In the old days we put them all on aspirin but as this is not effective and there carries a significant risk of bleeding with anticoagulants so they tended to be given advice and possibly stockings. Thus whether care has not been satisfactory is difficult to determine.It has to be remembered that even with perfect prophylaxis there is a risk of DVT and pulmonary embolus. Pulmonary embolus can be fatal and DVT can lead to post-thrombotic syndrome with long term consequences for the patient.

Infection is a major orthopaedic problem.If it is superficial it will settle easily but if deep in the joint it can be difficult to cure and be permanent,resulting in long term antibiotics or amputation.

For this reason most orthopaedic operations with the exception of arthroscopy are covered by prophylactic antibiotics. The common drug would be a cephalosporin. This would usually be given on induction of anaesthesia, 15mins prior to elevation of the tourniquet, ( if the tourniquet is inflated neither blood nor antibiotic would get through), and two further doses in the ward at 6 hourly intervals. Giving a longer course risks side effects and emergence of resistance. Some surgeons give more recently developed drugs in combination because of resistance and many hospitals have a protocol which should be followed. However if a surgeon followed a well recognised drug scheme this would be supportable even if his hospital’s protocol was different. Although Im not planning to discuss infection and its treatment, despite all this being undertaken there is a risk that a deep infection may occur (1-2% after joint replacement) and this would not be negligent although delayed diagnosis and poor treatment might be.

The tourniquet is a frequently used tool in limb surgery. The aim is to block arterial blood flow into the limb. This means it needs to be inflated to a pressure well above the systolic BP. Most tourniquets are automatic and inflate to the correct level with the flick of a switch. Very high uncontrolled pressure would cause tissue damage but the main danger is the time the tourniquet is inflated. The maximum time a leg tourniquet should be inflated is 2 hours. If an operation is to take longer the tourniquet can be deflated to allow blood flow and reinflated 20 minutes later. If the op is to be very long the tourniquet could be avoided. Where there is less risk of bleeding a surgeon could place the tourniquet in position but inflate it only if bleeding occurs. When the tourniquet is inflated and when deflated should be recorded on the anaesthetic sheet as should the tourniquet time (the time it was inflated).

There have been papers that suggest that anoxia occurs in the tissues with any tourniquet and some surgeons prefer to avoid tourniquets completely using other means of haemostasis.

Has the operation been performed satisfactorally? The first question is whether the right operation has been chosen in the first place. Some surgeons are adventurous, which might be good in certain circumstances, but they should be able to back up their advice with the literature and their experience.

The surgeon performing an operation for the first time without backup is a no-no these days.

Some surgeons use unorthodox items in surgery. We used to use a teaspoon to protect the artery and nerves in knee surgery with good effect,it worked perfectly and safely. However to use an instrument in an unorthodox way and against the recommendations of the manufacturer is never wise. A colleague who used a haemostasis machine in which the active agent was intended to be propelled by the air. merely used the air alone injecting a large amount of air into his patient resulting in a fatal air embolus. He was rightly severely criticised and faced a GMC tribunal.

The surgeon must be capable and trained to do the operation.All consultants appointed must have a Certificate of Higher Surgical training after passing their FRCS (Orth). This is a Royal College of Surgeons requirement and they need to be on the Specialist Register with the GMC.

With all types of surgery being so highly specialised the training usually includes time in a specialist unit with a main interest for example in Hands,Spines or Knees. Any surgeon working outside his trained area would be liable for criticism. The surgeon should be doing a number of that type of operation per year to be regarded as competent and retaining his/her skills.

Numbers have been bandied about concerning the number of operations required but this has always been challenged and does depend on the area of the country where one works, whether densely populated or not.There is a story that in the US it is quite common for some surgeons to do only one operation of a specific type,eg total knee replacement, per year. I wouldn’t want to be that surgeon’s patient! So it is worth asking about the surgeons training and his practice although such information can be difficult to obtain.

These days there are registers of the results of operations particularly Total Hip Replacement and Knee Replacement and others for say Ligament surgery are starting up. Although it is possible to obtain the results of surgery from the hospital individual figures are limited to a few people only.

In general in the UK there are a number of straightforward procedures which most surgeons could perform successfully.

Checking on the procedure performance is not easy from the notes,most surgeons will try to gloss over “difficulties” and play down any problems. If a problem happens during an operation which is unexpected a good surgeon will explain what has happened,why it has happened and his correction of it. Such a surgeon who argues effectively is not likely to be negligent, although unexpected division of a nerve or major vessel might be an exception.

If the op cant be judged from the notes in orthopaedics there is always the Xray! Xrays can be illuminating and the current computer Xrays can be measured accurately more so than measuring the old films with a ruler. Clearly no one is expected to be perfect and in all circumstances there is an allowed variant which can be questioned between experts. Examination and measuring of Xrays can be very helpful in determining negligence. So that if the leg for instance is very bow-legged or the implant at a major angle to what it should be this should be clearly shown.

If something does go wrong the patient will often ask for a second opinion. To assess that opinion its important to know who’s giving it. The advice should be from a specialist with a practice of giving such opinions. Usually at this stage the expert is only examining the notes etc to give an opinion but to have a letter after a second examination can be extremely helpful. Recently I was asked for advice concerning a painful knee replacement with mild instability based on the hospital notes. After seeing the second opinion letter it was clear that the knee was grossly unstable in all directions which could only come from a negligently performed operation and wrote to the instructing solicitor changing my own opinion.

I have attempted to cover most of the areas around an orthopaedic operation where negligence can be considered.Patients are often very definite in the area
where they think they’ve been wronged.It is the duty of the expert to consider all the medical records and produce an independent view.I usually read the patients statement which is very helpful although I don’t normally include in the first report giving my advice. Patients/claimants often have a very clear view of events which is at odds with the notes. Their memory is clear that usually after a conference their statement views can be included adjacent to the notes.

One of the causes of negligence claims is that a surgeon might say “if only you’d seen me 20 years ago this wouldnt have happened”. Naturally such a patient would immediately go and see a solicitor!

I advised on such a case for the defence.The patient had a femoral fracture around 1970. As might be expected for the time it was declared inoperable by any experienced surgeon who normally did operate on fractured femurs. It was treated in traction for 3 months.After 3 months he was treated in POP for a further 3 months.The only notes from the first 3 months was a transfer letter and there were no Xrays. The letter stated that the fracture was in good position. After plaster removal the leg was extremely stiff angulated and shortened and he had numerous operations in an attempt to correct this. The surgeons
off the cuff remark occurred in the 1990’s.

The argument centred around what was acceptable in the 1970’s ( and which wouldn’t have been accepted now). The claimants advisor said that the position was not acceptable and if it was acceptable on transfer (viz the letter) it must have occurred whilst in plaster. There were no xrays over any of his original treatment.We argued that there was no evidence of this as acceptable in the 1970’s was totally different from the 1990’s or today. The case was withdrawn
one week before trial. Its clear all surgeons should be careful what they say and if they feel there is malpractice they should document it.